D-0365-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- August 22, 2017
- Termination Date
- December 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,644 cases
Product Description
Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6013 UPC 6 18029 80008 4
Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Distribution Pattern
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Code Information
Product Code: 6013; Lots: 51361, EXP 8/8/2017; 51834, EXP 9/6/2017; 52473, EXP 10/17/2017; 53225, EXP 11/28/2017; 54102, EXP 1/30/2018; 54754, EXP 3/13/2018; 55222, 55264, EXP 4/10/2018, 56683, EXP 7/17/2018; 57262, EXP 8/21/2018; 57803, EXP 9/18/2018; 58492, EXP 10/30/2018; 59311, EXP 12/4/2018; 60069, EXP 11/27/2018; 61063, EXP 3/19/2019; 61629, EXP 4/17/2019.